Clinical investigations: compiling a submission

Key changes

Clarified safety data requirements for device clinical investigation submissions; updated submission process for MHRA assessment.

PV impact

The revised guidance dictates how manufacturers must prepare and submit safety data for medical device clinical investigations in the UK. This impacts clinical safety teams' processes for compiling safety reporting and clinical data for MHRA review, ensuring compliance with the UK Medical Device Regulations 2002.

Exact policy details

Clinical investigation submission requirements

Documentation must include certain information when applying for approval for a clinical investigation.

Applies to: Manufacturers of medical devices undertaking clinical investigations.

This guidance will help manufacturers to submit the correct information. · p. 1 · High · Source

Updates on clarification of certain standards

Clarified points around software standard IEC 62304, device labeling, essential requirements, risk analysis, and cover letter.

Applies to: Manufacturers submitting clinical investigation proposals.

Updates to the 'Submitting a clinical investigation proposal for MHRA assessment' document. · p. 1 · High · Source

Extracted documents

• Clinical investigations: compiling a submissionhtmlhtml · high · 1 page